Associate Engineering Manager
Core
Senior Manufacturing Engineer leading manufacturing engineering duties, process improvement, and equipment qualification in a medical device environment.
Role type
Senior Manufacturing Engineer (Engineering Manager)
Builds
Manufacturing processes, documentation, and commercial product introductions
Domain
Medical Technology / Manufacturing Engineering
Required skills
Manufacturing process design, Equipment qualification, Process improvement, Project management, Technical report writing, Cross-functional leadership, Problem solving, Capacity planning, Budget development, Calibration management
Preferred skills
Line transfer experience, BSC systems expertise, International project travel
Technologies
CGMP, BOMs, NCEP, CAPA, BSC systems
Responsibilities
Identify, order, and commission key process equipment to CGMP standards; Develop and modify manufacturing documentation and procedures for new products; Ensure new products meet business, quality, output, and cost goals; Develop and modify manufacturing processes to improve quality and output; Perform product/process/vendor qualification activities; Support material discrepancy review and disposition activities; Eliminate/reduce product/process defects and improve yields; Support quality and corrective/preventive actions initiatives; Maintain a valid capacity model and conduct advance planning for capital; Train cross-functional team members including engineers and technicians; Develop expert knowledge on BSC systems; Provide equipment calibration services and manage calibration standards; Research and acquire new standards and capital equipment; Develop department fiscal year budgets.
Seniority
Senior, hands-on IC with leadership responsibilities